BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Steerant™ Super Stiff Guidewire

    Reg #: 9681477 · FEI: 3002807439 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LAKE REGION MEDICAL LIMITED
    Registration Number
    9681477
    FEI Number
    3002807439
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BUTLERSLAND
    City
    NEW ROSS Wexford
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K232570

    Owner / Operator

    Firm Name
    Lake Region Medical
    Operator Number
    2126666
    Address
    340 Lake Hazeltine Drive, --
    City
    Chaska
    State
    MN
    Postal Code
    55318
    Country
    US

    US Agent

    Business Name
    Lake Region Medical
    Contact Name
    Paul Trnka
    Address
    340 Lake Hazeltine Dr
    City
    CHASKA
    State
    MN
    ZIP
    55318
    Country
    US
    Email
    [email protected]
    Phone
    952 6418396

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    Steerant™ Super Stiff Guidewire

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)